510(k) Report

Devices descending from K050704

7 later devices reach Modification to: Revolution XR/D Digital Radiographic Imaging System with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143270Optima XR646Ge Hualun Medical Systems Co., Ltd.20156—
+2K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd.201751
+3K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd.202311
+3K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd.201913
+3K173612Optima XR646 HDGe Hualun Medical Systems Co., Ltd.201701
+4K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd.20250—
+4K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd.20240—